PI Oversight: What Is It, Actually?
*Collaboration & Partnership
Lack of PI oversight is one of the most frequent FDA audit findings. This makes it one of the most important activities for your site to dedicate time to improving. A thorough understanding of ICH, GCP and FDA guidelines is critical! You will leave this session with tips, tricks and techniques to avoid inspection findings by showing PI oversight and demonstrating that your PI is fully involved and well-informed.
Steve Satek, Founder & President, Great Lakes Clinical Trials
Dan Otap, CCRP, Sr. Alliance & Partnership Leader, Genentech
Irene Axelrod, RN, CCRC, Founder, Boston Clinical Trials
Jing Bao, MD, PhD, Co-Founder & Chief Medical Officer, Drug Development and Filing Consulting (DDFL), LLC
Chris O’Shaughnessy, Vice President of Business Development, Curavit
Advanced Social Media Tactics That Work
*Development & Marketing
Most patient recruitment experts agree that social media works. The problem is knowing which social media tactics generate the results you need, when you need them. This session will walk you through advanced social media strategies and tactics to help you consistently meet your enrollment goals.
Matt Miller, President & CEO, StudyKik
Miaesha Campbell, Director of Patient Recruitment & Retention, Medpace
Wes Bonner, VP, Strategic Development, Meridian Clinical
The Competent Investigator Understands Both Compliance and Excellence
This interactive session will focus on the skills needed to make an excellent investigator by comparing compliance and excellence in research. Real life examples will be discussed to understand how an investigator views and responds to compliance regulations in clinical context.
Michael Koren, MD, CEO, Jacksonville Center for Clinical Research
Trust-Building: Utilizing Your Data to Validate Your Site
*Digitalization, Data & Technology
With sponsors and CROs having increased awareness of sites’ potential patient access, gone are the days when studies were awarded based on site information forms or site selection visits alone. This session will help you understand the data sources that sponsors and CROs are using to further validate your site and provide perspective on what kinds of data you should keep and share to position your site for selection.
Barry Lake, CEO & Co-Founder, Devana Solutions®
Kerry Gorman, Director, Strategic Site Solutions, IQVIA
Jeff Stein, President, Stamford Therapeutics Consortium
Exploring the Meaning of Diversity & How it Impacts the Clinical Research Site
The importance of including and enrolling diverse patient populations in clinical research studies continues to gain momentum. In 2017, SCRS took a strong stance on this topic with the creation of the Diversity Awareness Program to evaluate and measure the inclusion of diverse patients globally. Join this session to learn about the SCRS Diversity Program while providing feedback in an interactive focus group. The discussion aims to engage participants with perspective and knowledge on the enrollment of diverse patient populations at your site and in your region or community.
Diana Foster, PhD, VP, Strategy and Special Projects, Society for Clinical Research Sites
Fabian Sandoval, MD, President & CEO, Emerson Clinical Research Institute
Karri Venn, RD, CDE, CCRC, President, Research, LMC Manna Research
Operational Strategies In Uncertain Times
We all know that things have been hard over the past year and many sites have struggled to keep the lights on. In this session, hear from experts about what you need to pay closest attention to operationally and financially to keep your good work on track and to mitigate the possibility of shutting down studies and sites.
Christin Trujillo, Financial Consultant, Maven Financial Partners
Scott Palmese, MS, Senior Director Site Networks Mobilization Lead, Accellacare
Steve Clemons, MSN, FNP-BC, NP-C, President & CEO, VitaLink Research
Amy DeWerth, Strategic Account Lead, Janssen Pharmaceuticals
Using Patients Stipends to Establish Fair Market Value
Creating an appropriate patient compensation plan is an important aspect of recruitment and retention success. But how do sites know what the industry benchmark is in order to establish a level playing field? During this session, sites and other industry representatives will share their experience and perspective on payment information for specific indications and identify Fair Market Value for patient stipends.
Kristine Majors, RN, MS, President/Director of Research, Integrated Clinical Trial Services, Inc.
Rochelle Redding, MS, CPM, Associate Director Global, Site Budgets and Payment, Merck
Wayne Baker, Chief Commercial Officer, Greenphire
Dissecting a Clinical Trial Agreement
*Legal, Operations & Administration
Clinical trial agreements (CTAs) are lengthy, detailed, and often difficult to understand. How does your site navigate breaking down a typical CTA? Speakers will identify key sections to hone in on and pay attention to, bring attention to oft-negotiated sections, and share resources such as SCRS’ CLEAR guidelines that provide sites with support in the process.
Michael Pierre, Sr. Director of Systems Management, Meridian Clinical Research
Chuck DeMars, MS, Corporate Director of Budgeting & Contracting, CenExcel Clinical Research
Joey Nguyen, MEd, Site Services & Training Manager, ClinEdge
Enrollment & Engagement: How to Acquire & Keep Patients in Trials Using Data-Driven Decisions
We live in a world where we need to compete for time and loyalty when it comes to everything from health to ice cream. In this session, learn how to enroll top patients and how to keep them by using behavioral science data to make your decisions.
Sarah McKeown-Cannon, Director, Strategic Relationships, Langland, a Publicis Health Company
Kyle Hogan, Chief Strategy & Marketing Officer, Datacubed Health
Lisa Bjornestad, Director, Site Alliance, Parexel, The Americas
Dave Billiter, MBA, CEO & Co-Founder, Deep Lens
Managing Burnout in a Post-Pandemic Age
We have never been through something like this before in our lifetime. And while many of us are doing “just fine”, the grind of balancing work and life during the pandemic has taken a toll. In this session, learn how we can take better care of our patients, our team, and ourselves as we discuss how to manage burnout in a post-pandemic era.
Blake Adams, VP, Marketing, Florence Healthcare
Doug Schantz, VP, Head of Clinical Operations, Alexion Pharmaceuticals
Ryan Clemons, PharmD, RPh, Vice President of Business Development and Science Innovation, BlueCloud® by HealthCarePoint
The Best Staffing Models for Better Quality, Enrollment & Margins
The right staffing model can quickly turn an average site into a high-performing site with efficient operations. But which staffing model is the right fit for your staff and capabilities? This session will identify why most traditional staffing models underperform and share ways to realign job functions to match staffing skills and credentials.
Kelly Sanford, MSHS, PMP, CCRA, Head of Decentralized Trials Solutions, Site Operations, IQVIA
Scott Whitt, MA, President & General Manager, Triad Clinical Trials
Nicole Mills, MS, ACRP-CP, Director, Clinical Research, Medix
Marianne Tadros, CCPM, ACRP-PM, Director of Human Resources, DM Clinical
A Shared Vision: Boosting Your Research Operations
*Legal, Operations & Administration
Establishing a shared vision for clinical research within your organization will support the alignment of your large physician group or hospital system’s research operations. Speakers will provide an administrative overview of the clinical, regulatory, and financial risks of a research business line and discuss how to determine the best research staffing model to drive quality and profitability.
Matt Lowery, ACRP-CP, Executive Director, CRBD+
Michele Cameron, MBA, BSN, RN, CCRC, Dir. Clinical Research, Clearwater Cardiovascular Consultants
Rick Baransky, Senior Director, Site Networks, Accellacare
Study Start-Up: Beyond Regulatory, Budgets & Contracts
When our industry thinks of study start-up, we mainly focus on regulatory documents and fully executed contracts. We often overlook the other components that also need to be in place before screening the initial patient. In this session, sites will share lessons learned and must-do’s before starting a study.
James Riddle, MCSE, CIP, CPIA, CRQM, VP, Research Services & Strategic Consulting, Advarra
Henry Kravchenko, Founder & CEO, Clinical.ly
Roman Fishchuk, MD, MSc, CEO, Central City Clinical Hospital